Cra
hace 7 meses
Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.Contributes to other project work and initiatives for process improvement, as required.
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Cra Manager
hace 2 meses
Santiago de Chile MSD A tiempo completoThis role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager the role is...
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Associate Cra
hace 2 meses
Santiago de Chile MSD A tiempo completoWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...
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Cra I, Cra Ii or Senior Cra, Single-sponsor
hace 2 meses
Santiago de Chile ICON Plc A tiempo completoCRA I, CRA II, Sr. CRA - Chile, Santiago ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate...
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Cra Ii
hace 2 meses
Santiago de Chile ICON Plc A tiempo completoCRA II or Senior CRA, Santiago, Chile ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate II...
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Cra Ii
hace 2 meses
Santiago de Chile Icon plc A tiempo completoCRA II or Senior CRA, Santiago, Chile ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate II...
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Assistant Cra
hace 7 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve...
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Assistant Cra
hace 7 meses
Santiago de Chile Thermo Fisher Scientific A tiempo completo**Description - External** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to...
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Senior Cra or Cra Ii
hace 2 meses
Santiago de Chile ICON Plc A tiempo completoCRA II or Senior CRA - Santiago, Chile - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development **What you will be doing**: As a Clinical...
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Cra Ii
hace 7 meses
Santiago de Chile ICON plc A tiempo completo**Experienced CRA - Santiago, Chile, home-based role** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre...
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Sr Cra
hace 7 meses
Santiago de Chile Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
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Associate Director Clinical Research
hace 3 semanas
Santiago de Chile AstraZeneca A tiempo completoObjetivo del Puesto: El Director Asociado de Investigación Clínica (ADCR) es responsable de entregar la parte comprometida de todos los estudios clínicos de intervención bajo su supervisión de acuerdo con los recursos acordados y los cronogramas que cumplan con los Documentos de procedimiento de AZ, las pautas internacionales como ICH-GCP y las...
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Cra I
hace 7 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...
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Senior Cra
hace 2 meses
Santiago de Chile ICON Plc A tiempo completoSenior CRA - Argentina, Buenos Aires ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research...
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Cra Ii
hace 3 meses
Santiago de Chile Icon plc A tiempo completoCRA II - Chile, Santiago ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What ICON can offer you: - Our success depends on the quality of our...
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Cra Ii
hace 3 meses
Santiago de Chile Icon plc A tiempo completoCRA II - Santiago, Chile - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our diverse teams...
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Senior Cra
hace 3 meses
Santiago de Chile Icon plc A tiempo completoSenior CRA - Santiago, Chile - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our diverse...
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Cra I
hace 7 meses
Santiago de Chile Fortrea A tiempo completoSite monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Essential Job Duties: 1) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical...
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Senior CRA
hace 4 semanas
Chile ICON A tiempo completoAs Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will...
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Cra Ii
hace 6 meses
Santiago de Chile ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A CRA is a professional who contributes to accelerated drug/device/outcomes research through...
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Cra I
hace 7 meses
Santiago de Chile ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. A CRA is a professional who contributes to accelerated drug/device/outcomes research through...
